Safety, Toleration and Efficacy of Single Inhaled Doses of PF-00610355 in Chronic Obstructive Pulmonary (COPD) Patients. (A7881010)

October 27, 2010 updated by: Pfizer

A Phase 2A, Double Blind (3rd Party Open), 4 Way Cross-Over, Placebo Controlled Study To Investigate The Pharmacokinetics, Safety, Toleration And Efficacy Of Single Inhaled Doses Of PF-00610355 In Moderate COPD Patients.

This study will look at the pharmacokinetics, safety, toleration and efficacy of PF-00610355 in the chronic obstructive pulmonary disease (COPD) population. The doses in this study are intended to explore the anticipated clinical dose range.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

20

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
      • Berlin, Germany, 10117
        • Pfizer Investigational Site
      • Wiesbaden, Germany, 65187
        • Pfizer Investigational Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

40 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Post-bronchodilator FEV1/ FVC ratio of <0.7.
  • Post bronchodilator FEV1 of 50-80% (inclusive) of predicted.
  • Body Mass Index (BMI) of less than 35 kg/m2; and a total body weight greater that 40 kg.
  • Current smokers, or ex-smokers who have abstained from smoking for at least 6 months.

Exclusion Criteria:

  • Subjects having more than 2 exacerbations requiring treatment with oral steroids or hospitalization for the treatment of COPD in the previous year.
  • History of lower respiratory tract infection or significant disease instability during the month preceding screening or during the period between screening and randomization.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Placebo
Drug: Placebo
Placebo
Experimental: PF- 00610355
Drug: PF-00610355
dry powder inhaler, 1472 mcg, single dose
Drug: PF-00610355
dry powder inhaler, 736 mcg, single dose
Drug: PF-00610355
dry powder inhaler, 368 mcg, single dose
Experimental: PF-00610355
Drug: PF-00610355
dry powder inhaler, 1472 mcg, single dose
Drug: PF-00610355
dry powder inhaler, 736 mcg, single dose
Drug: PF-00610355
dry powder inhaler, 368 mcg, single dose
Experimental: PF -00610355
Drug: PF-00610355
dry powder inhaler, 1472 mcg, single dose
Drug: PF-00610355
dry powder inhaler, 736 mcg, single dose
Drug: PF-00610355
dry powder inhaler, 368 mcg, single dose

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
To characterize the single dose pharmacokinetics of inhaled PF-00610355 in COPD patients.
Time Frame: up to 8 days post dose
up to 8 days post dose
To evaluate the safety & toleration of single inhaled doses of PF-00610355 in COPD patients
Time Frame: up to 24 hours post dose
up to 24 hours post dose

Secondary Outcome Measures

Outcome Measure
Time Frame
To investigate the efficacy of a single inhaled dose of PF-00610355 in COPD patients.
Time Frame: up to 24 hours post dose
up to 24 hours post dose
To investigate the exposure/response relationship of PF-00610355.
Time Frame: up to 8 days post dose
up to 8 days post dose

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Pfizer

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2008

Primary Completion (Actual)

March 1, 2009

Study Completion (Actual)

March 1, 2009

Study Registration Dates

First Submitted

October 30, 2008

First Submitted That Met QC Criteria

October 30, 2008

First Posted (Estimate)

October 31, 2008

Study Record Updates

Last Update Posted (Estimate)

November 1, 2010

Last Update Submitted That Met QC Criteria

October 27, 2010

Last Verified

October 1, 2010

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • A7881010

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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